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Sonic Shot GX Injector

FDA 510(k)

Class II (US FDA 510(k))

510(k) K091734

by Nemoto Kyorindo Co., Ltd.

Identifiers

510(k) Number
K091734 FDA 510(k)
FDA Product Code
IZQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1650 FDA 510(k)
Regulation Number
870.1650 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Sonic Shot GX is an Automatic Injector for Contrast Media, designed to deliver intravenous contrast agents during medical imaging procedures. It is classified as a Class II device under FDA regulations and is specifically engineered for use in magnetic resonance imaging (MRI) environments. The device ensures precise, high-pressure injection of contrast media, facilitating clear visualization of vascular structures and organs.

This injector is supplied as a reusable medical device, featuring a non-magnetic body structure to ensure compatibility with MRI systems. It operates using an ultrasonic motor and is intended for use in cardiovascular applications, adhering to FDA clearance under the 510(k) pathway with a Substantially Equivalent determination. The device is regulated under 21 CFR 870.1650 and is manufactured by Nemoto Kyorindo Co., Ltd., with a product code of IZQ. Sterility and maintenance protocols are manufacturer-specified, and its design prioritizes ergonomic handling and MRI-safe operation.

Frequently asked questions

What is the Sonic Shot GX used for?

The Sonic Shot GX is an automatic injector designed specifically for delivering intravenous contrast media during medical imaging procedures. Its primary use is in magnetic resonance imaging (MRI) environments, where it provides precise, high-pressure injections to enhance visualization of vascular structures and organs. This makes it particularly valuable in cardiovascular applications, where clear imaging is critical for accurate diagnosis.

Is the Sonic Shot GX reusable or single-use?

The Sonic Shot GX is supplied as a reusable medical device. This design choice allows for cost-effective use across multiple procedures while maintaining the device’s performance and reliability. However, sterility and maintenance protocols must be strictly followed as specified by the manufacturer to ensure safe and effective reuse.

How does the Sonic Shot GX ensure compatibility with MRI systems?

The Sonic Shot GX is engineered with a non-magnetic body structure, which is essential for safe operation within MRI environments. This ensures that the device does not interfere with the magnetic fields used in imaging, reducing the risk of artifacts or patient safety hazards. Its ultrasonic motor also contributes to its MRI-safe functionality.

What regulatory pathway does the Sonic Shot GX follow?

The Sonic Shot GX is regulated under the FDA’s 510(k) pathway with a Substantially Equivalent determination, classified as a Class II device. This means it has been reviewed and cleared as safe and effective for its intended use in cardiovascular imaging. The device is also governed by 21 CFR 870.1650, which outlines specific regulatory requirements for automatic injectors.

What maintenance or storage requirements does the Sonic Shot GX have?

The Sonic Shot GX requires adherence to manufacturer-specified sterility and maintenance protocols to ensure proper functionality and safety. Since it is reusable, it must be cleaned, disinfected, and inspected between uses according to the guidelines provided by Nemoto Kyorindo Co., Ltd. Storage should follow the manufacturer’s instructions to prevent damage or contamination, particularly in environments where it may be exposed to MRI systems or other medical equipment.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Nemoto Kyorindo co., Ltd. | Sonic Shot GX injector for MRI, SONIC SHOT 7｜For MRI｜Our Products｜Nemoto, NEMOTO KYORINDO CO.,LTD. 070 SONIC SHOT GX - RevMed, SONIC SHOT GX 070 Nemoto SONIC SHOT GX contrast… - FDA.report, Nemoto

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nemoto Kyorindo Co., Ltd.

Sources (1)

  • FDA 510(k) K091734 24 fields · synced Oct 1, 2026